DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a system/device for incontinence prediction, classified in A61B 5/7275.
II. Claim 20, drawn to a method for incontinence prediction, classified in A61B5/7275.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, Invention II could be practiced with any generic/conventional EIT device using electrodes and processor(s).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I requires searching in A61B5/7275 for system & device level searching with queries related to flexible garment, posture detector, electrodes, undergarment, image, impedance, etc.
Invention II requires searching in A61B5/7275 for method level searching requiring search queries related to classification steps for determining bladder status, incontinence risk steps, incontinence events & voiding, comparative steps, etc.
-the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
-the prior art applicable to one invention would not likely be applicable to another invention; and
-the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Anthony Pisano on 28th April 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 2 & 7 are objected to because of the following informalities:
Claim 2 ‘comprises a an empty…’, should read ‘comprises an empty…’.
Claim 7 ‘a AC/DC converter’, should read ‘an AC/DC converter’.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6 & 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3, 6 & 17 recite ‘truth of an incontinence event’, it is unclear what the scope of the use of ‘truth’ in this limitation intends, rendering claims 3, 6 & 17 indefinite. Examiner interprets the limitation to read ‘an incontinence event’ as best understood by the disclosure.
Claims 5 & 16, ‘truth of the subject incontinence events’, it is unclear what the scope of the use of ‘truth’ in this limitation intends, rendering claims 3, 6 & 17 indefinite. Examiner interprets the limitation to read ‘an incontinence event’ as best understood by the disclosure.
Claims 6 & 18, ‘truth of user incontinence events’, it is unclear what the scope of the use of ‘truth’ in this limitation intends, rendering claims 3, 6 & 17 indefinite. Examiner interprets the limitation to read ‘an incontinence event’ as best understood by the disclosure.
Claims 4, 5, 15 & 16, ‘subject’, it is unclear if the term subject is meant to refer or pertain to the previously recited ‘user’, or if the previously recited ‘user’ is included in limitations involving the term ‘subject’ or not, rendering Claims 4, 5, 15 & 16 indefinite. Examiner interprets the term ‘subject’ to not refer to or pertain to the previously recited ‘user’, instead ‘subject’ is interpreted to be historical sample data from other users that do not include the ‘user’ as claimed.
Claim 7, ‘image parts’, it is unclear what is meant by image parts in this limitation and the specification does not provide clarity on the term image parts or support for any other term, rendering Claim 7 indefinite. Examiner interprets image parts to intend ‘imaginary parts’, as real parts and imaginary parts would be inherently generated using an analog to digital converter, as best understood by the disclosure.
Claim 7, ‘a AC/DC converter and an analog-to-digital converter to generate real parts and image parts of electrical impedance’, this limitation currently reads as if both the AC/DC converter and analog-to-digital converter are used to generate real parts and imaginary parts (see interpretation above.). It is unclear how an AC/DC converter and an analog-to-digital converter both generate imaginary parts, rendering claim 7 indefinite. Examiner interprets this limitation to intend only the analog-to-digital converter generating real parts and imaginary parts, as best understood by the disclosure.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-19 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-19 recites at least one step or instruction for collecting data, making determinations based on data, making predictions based on data, outputting data, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG.
Accordingly, each of Claims 1-19 recites an abstract idea.
Specifically,
Claim 1, A system for incontinence prediction, comprising: an electrical impedance tomography (EIT) device comprising a plurality of electrodes configured to be worn at a lower abdomen of a user around a bladder, wherein a first two or more electrodes are configured to apply alternating currents to a body of the user, and a second two or more electrodes record resulting potentials detected in the body of the user; and a posture detector, wherein one or more processors communicatively coupled to the EIT device and the posture detector is configured to: collect an EIT image generated by the EIT device, a posture generated by the posture detector, and a planning activity of the user (Observation); determine a bladder status based on the EIT image of the user (Judgement); predict an incontinence risk based on the bladder status, the posture, and the planning activity of the user and determine a high-risk point indicating a high incontinence risk (Evaluation/Opinion); and notify the user or a caregiver of the high incontinence risk at the high-risk point (Observation).
Claim 11, An garment for incontinence prediction, comprising: a garment body formed of a flexible fabric, wherein the garment body is configured to be worn on a lower torso of a user; an electrical impedance tomography (EIT) device comprising a plurality of electrodes arranged at discrete locations on the garment body, wherein each electrode is positioned on an inner surface of the garment body and is configured to contact at a lower abdomen of the user around a bladder; a posture detector arranged at the inner surface of the garment body; and one or more processors communicatively coupled to the EIT device and the posture detector, the one or more processors configured to: collect an EIT image generated by the EIT device, a posture generated by the posture detector, and a planning activity of the user (Observation); determine a bladder status based on the EIT image of the user (Judgement); predict an incontinence risk based on the bladder status, the posture, and the planning activity of the user (Evaluation/Opinion) and determine a high-risk point indicating a high incontinence risk (Judgement); and notify the user or a caregiver of the high incontinence risk at the high-risk point (Observation).
The underlined portions of which resemble mental processes (e.g., (observation, measuring, interpreting data, judgement, or evaluation, which is grouped as a mental process under the 2019 PEG)
Further, dependent Claims 2-10 & 12-19 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 & 11 (and their respective dependent Claims 2-10 & 12-19) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1 & 11), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: electrical impedance tomography (EIT) device, plurality of electrodes, posture detector, one or more processors incontinence event detector, are generically recited computer elements in independent Claims 1 & 11 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1 & 11 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., one or more processors as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1 & 11 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 & 11 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-19 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: electrical impedance tomography (EIT) device, plurality of electrodes, posture detector, one or more processors, incontinence event detector, a garment.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, electrical impedance tomography (EIT) device (Para. [0005]), plurality of electrodes (Para. [0028]), posture detector (Para. [0035]), one or more processors (Para. [0040-0041]), incontinence event detector (Para. [0026]), and a garment body (Para. [0050]).
Accordingly, in light of Applicant’s specification, the claimed term one or more processors is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the one or more processors. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-19 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and device of Claims 1-19 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-19 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 & 11 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-19 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-19 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-19 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 8-11, 13-14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over AU 2020289809 A1 to Loughney et al. (hereinafter, Loughney) in view of US 20170065821 A1 to Brink et al. (hereinafter, Brink).
Regarding Claim 1, Loughney discloses a system for incontinence prediction (Loughney: Abstract), comprising:
an electrical impedance tomography (EIT) device comprising a plurality of electrodes configured to be worn at a lower abdomen of a user around a bladder (Loughney: Pg. 15, lines 21-24; Pg. 19, lines 20-25; Figs. 3A & 3B),
wherein a first two or more electrodes are configured to apply alternating currents to a body of the user, and a second two or more electrodes record resulting potentials detected in the body of the user (Loughney: Pg. 15, lines 21-24); and
collect an EIT image generated by the EIT device (Loughney: Pg. 15, lines 24-26),
determine a bladder status based on the EIT image of the user (Loughney: Pg. 22, lines 1-9).
Loughney is silent on generating a posture by a posture detector and a planning activity of the user, predicting an incontinence risk based on the bladder status, posture, and planning activity, determining a risk of incontinence, and notifying the user of the risk of incontinence.
However, Brink teaches a posture detector, a posture generated by the posture detector (Brink: Para. [0087]), and a planning activity of the user (Brink: Para. [0088]);
predict an incontinence risk based on the bladder status, the posture, and the planning activity of the user and determine a high-risk point indicating a high incontinence risk (Brink: Para. [0049]; [0065]); and
notify the user or a caregiver of the high incontinence risk at the high-risk point (Brink: Para. [0049]; [0065]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include a posture detector and incontinence risk as taught by Brink because patient activity level exceeding a threshold based on motion signals may indicate an increase in probability of an involuntary voiding event will occur (Brink: Para. [0065]) and to inform the user of their need to empty their bladder (Brink: Para. [0049]).
Regarding Claim 2, Loughney in view of Brink discloses the system of claim 1, Loughney further discloses wherein the bladder status comprises a an empty status, a half-full status, a three-fourths full status, and a full status (Loughney: Pg. 22, lines 1-9; Pg. 9, lines 9-11 & Pg. 9, line 31-Pg. 10, line 4; Pg. 18, lines 24-27; Fig 18A-F; Note: Examiner interpretation of Full status is based on the bladder just prior to micturition which is interpreted to be a ‘maximum bladder tolerance of the user’… a full bladder is the same as a largest liquid volume in the bladder, the images can be measured against a baseline that includes measurements taken just before micturition (full bladder) and after micturition (empty bladder) and between (during filling). Volume change measurements during periods of bladder filling is interpreted to encompass half-full and three-fourths full statuses.),
wherein the full status is based on a maximum bladder tolerance of the user, wherein the maximum bladder tolerance of the user corresponds to a largest liquid volume in the bladder based on collected historical EIT images since an initial usage of the EIT device by the user (Loughney: Pg. 16, line 27-Pg. 17, line 1; Pg. 18, lines 24-27 & Fig. 18A-F; Pg. 7, lines 16-17; Note: Examiner interpretation of Full status is based on the bladder just prior to micturition which is interpreted to be a ‘maximum bladder tolerance of the user’… a full bladder is the same as a largest liquid volume in the bladder, the images can be measured against a baseline that includes measurements taken just before micturition (full bladder) and after micturition (empty bladder) and between (during filling).).
Regarding Claim 3, Loughney in view of Brink discloses the system of claim 1, Loughney is silent on an incontinence event detector.
However, Brink teaches wherein the system further comprises an incontinence event detector to identify truth of an incontinence event and validate the predicted incontinence risk (Brink: Para. [0066] ‘moisture sensor’; [0049];[0065]),
wherein the incontinence event detector is attached to a diaper or a pad, and the incontinence event detector is a moisture sensor, a thermistor, or a resistance meter (Brink: Para. [0066] ‘undergarment’, ‘moisture sensor’; [0065]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include an incontinence event detector as taught by Brink to provide information indicative of voiding events that occur (Brink: Para. [0049], [00065-0066]).
Regarding Claim 8, Loughney in view of Brink discloses the system of claim 1, Loughney further discloses wherein the EIT device measures a bladder impedance corresponding to liquid volume in the bladder and a background impedance corresponding to background tissues, wherein the background impedance is constant and the bladder impedance changes according to liquid volume in the bladder (Loughney: Pg. 4, lines 28-32; Pg. 25, lines 26-33).
Regarding Claim 9, Loughney in view of Brink discloses the system of claim 1, Loughney is silent on postures.
However, Brink teaches wherein the posture comprises a sitting posture, a standing posture, a flat laying posture, an inclined laying posture, or a side laying posture (Brink: Para. [0088]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include postures as taught by Brink because postures indicate physical activity, which may be indicative of a fill level, a voiding event, or any other physiological marker related to the bladder fill cycle (Brink: Para. [0088]).
Regarding Claim 10, Loughney in view of Brink discloses the system of claim 1, Loughney is silent on a posture detector.
However, Brink teaches wherein the posture detector is configured to be worn around knees, hips, or thighs of the user (Brink: Fig. 1, item 22 appears to be around the thigh of the user.).
Regarding Claim 11, Loughney discloses a garment for incontinence prediction (Loughney: Abstract), comprising: a garment body formed of a flexible fabric, wherein the garment body is configured to be worn on a lower torso of a user (Loughney: Pg. 15, lines 21-24; Pg. 19, lines 20-25; Figs. 3A & 3B);
an electrical impedance tomography (EIT) device comprising a plurality of electrodes arranged at discrete locations on the garment body (Loughney: Pg. 17, lines 17-21; Figs. 5A & 5B; Pg. 17, lines 22-24; Pg. 19, lines 1-5; Pg. 15, lines 21-24),
wherein each electrode is positioned on an inner surface of the garment body and is configured to contact at a lower abdomen of the user around a bladder (Loughney: Pg. 17, lines 17-25; Figs. 5A & 5B; Pg. 15, lines 21-24; Pg. 19, lines 20-25; Figs. 3A & 3B); and
one or more processors communicatively coupled to the EIT device, the one or more processors (Loughney: Pg. 15, lines 7-12) configured to: collect an EIT image generated by the EIT device (Loughney: Pg. 15, lines 24-26),
determine a bladder status based on the EIT image of the user (Loughney: Pg. 22, lines 1-9);
Loughney is silent on generating a posture by a posture detector and a planning activity of the user, predicting an incontinence risk based on the bladder status, posture, and planning activity, determining a risk of incontinence, and notifying the user of the risk of incontinence.
However, Brink teaches a posture detector, a posture generated by the posture detector (Brink: Para. [0087), and a planning activity of the user (Brink: Para. [0088]);
predict an incontinence risk based on the bladder status, the posture, and the planning activity of the user and determine a high-risk point indicating a high incontinence risk (Brink: Para. [0049];[0065]); and
notify the user or a caregiver of the high incontinence risk at the high-risk point (Brink: Para. [0049];[0065]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include a posture detector and incontinence risk as taught by Brink because patient activity level exceeding a threshold based on motion signals may indicate an increase in probability of an involuntary voiding event will occur (Brink: Para. [0065]) and to inform the user of their need to empty their bladder (Brink: Para. [0049]).
Regarding Claim 13, Loughney in view of Brink discloses the garment of claim 11, Loughney further discloses wherein the garment body comprises a pair of undergarments, where the pair of undergarments is a pair of boxers, a pair of briefs, a pair of boxer briefs, a pair of trunks, a pair of midway briefs, or a pair of thermal underwear (Loughney: Pg. 11, line 32-Pg. 12, line 2 ‘shorts’ or ‘diaper’).
Regarding Claim 14, Loughney in view of Brink discloses the garment of claim 11, Loughney further discloses wherein the bladder status comprises an empty status, a half-full status, a three-fourths full status, and a full status, wherein the full status is based on a maximum bladder tolerance of the user, the maximum bladder tolerance of the user corresponds to a largest liquid volume in the bladder based on collected historical EIT images since an initial usage of the EIT device by the user (Loughney: Pg. 16, line 27-Pg. 17, line 1; Pg. 18, lines 24-27 & Fig. 18A-F; Pg. 7, lines 16-17; Note: Examiner interpretation of Full status is based on the bladder just prior to micturition which is interpreted to be a ‘maximum bladder tolerance of the user’… a full bladder is the same as a largest liquid volume in the bladder, the images can be measured against a baseline that includes measurements taken just before micturition (full bladder) and after micturition (empty bladder) and between (during filling).).
Regarding Claim 19, Loughney in view of Brink discloses the garment of claim 11, Loughney is silent on postures.
However, Brink teaches wherein the posture comprises a sitting posture, a standing posture, a flat laying posture, an inclined laying posture, or a side laying posture (Brink: Para. [0088]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include postures as taught by Brink because postures indicate physical activity, which may be indicative of a fill level, a voiding event, or any other physiological marker related to the bladder fill cycle (Brink: Para. [0088]).
Claim(s) 4-6, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loughney in view of Brink in view of US 20220133259 A1 to Hwang et al. (hereinafter, Hwang).
Regarding Claim 4, Loughney in view of Brink discloses the system of claim 1,
Loughney further discloses EIT image data indicating subject bladder statuses, and incontinence data indicating subject incontinence events (Loughney: Pg. 16, line 27-Pg. 17, line 1; Pg. 18, lines 24-27 & Fig. 18A-F; Pg. 7, lines 16-17).
Loughey is silent on posture data indicating subject postures and an incontinence prediction module that is pretrained with pretraining data comprising posture data, EIT image data, and incontinence data.
However, Brink teaches posture data indicating subject postures (Brink: Para. [0049]; [0065]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include a posture detector and incontinence risk as taught by Brink because patient activity level exceeding a threshold based on motion signals may indicate an increase in probability of an involuntary voiding event will occur (Brink: Para. [0065]) and to inform the user of their need to empty their bladder (Brink: Para. [0049]).
Loughney in view of Brink is silent on an incontinence prediction module that is pre-trained with pretraining data comprising posture data, EIT image data, and incontinence data.
However, Hwang teaches an incontinence prediction module that is pre-trained with pretraining data comprising posture data, image data, and incontinence data. (Hwang: Para. [0017] and [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Regarding Claim 5, Loughney in view of Brink in further view of Hwang discloses the system of claim 4, Loughney further discloses in view of Brink discloses postures, bladder statuses, and incontinence events (See rejections of claims 1 above), but Loughney in view of Brink are silent on pretraining modeling dependence between the subject postures, the subject bladder statuses, and truth of the subject incontinence events.
However, Hwang teaches an incontinence prediction module wherein the pre-training is conducted by modeling dependence between data sets (Hwang: Para. [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Regarding Claim 6, Loughney in view of Brink in further view of Hwang discloses the system of claim 4, Loughney further discloses validation with historical data comprising EIT images since an initial usage of the EIT device by the user (Loughney: Pg. 16, line 27-Pg. 17, line 1; Pg. 18, lines 24-27 & Fig. 18A-F; Pg. 7, lines 16-17; Note: Examiner interpretation of Full status is based on the bladder just prior to micturition which is interpreted to be a ‘maximum bladder tolerance of the user’… a full bladder is the same as a largest liquid volume in the bladder, the images can be measured against a baseline that includes measurements taken just before micturition (full bladder) and after micturition (empty bladder) and between (during filling).).
Loughney is silent on an incontinence event detector and an incontinence prediction module.
However, Brink teaches an incontinence event detector to identify truth of an incontinence event (Brink: Para. [0049]; [0065-0066] ‘moisture sensor’),
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include an incontinence event detector as taught by Brink to provide information indicative of voiding events that occur (Brink: Para. [0049]; [0065-0066])
Loughney in view of Brink is silent on an incontinence prediction module.
However, Hwang teaches wherein the incontinence prediction module is validated with historical data comprising user postures, images, and truth of user incontinence events generated since an initial usage of the image device by the user (Hwang: Para. [0077]; [0017] and [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Regarding Claim 15, Loughney in view of Brink discloses the garment of claim 11, Loughney in view of Brink is silent on an incontinence prediction module that is pre-trained with pre-training posture-status data comprising posture data, EIT image data, and incontinence data.
However, Hwang teaches an incontinence prediction module that is pre-trained with pre-training posture-status data comprising posture data, image data, and incontinence data (Hwang: Para. [0017] and [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Regarding Claim 16, Loughney in view of Brink in further view of Hwang discloses the garment of claim 15, Loughney in view of Brink discloses postures, bladder statuses, and incontinence events (See rejections of claims 1-3 above). Loughney is silent on pretraining via modeling dependence between datasets.
However, Hwang teaches an incontinence prediction module wherein the pre-training is conducted by modeling dependence between data sets (Hwang: Para. [0017] and [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Regarding Claim 17, Loughney in view of Brink in further view of Hwang discloses the garment of claim 15, Loughney is silent on an incontinence event detector.
However, Brink teaches wherein the garment further comprises an incontinence event detector arranged at the inner surface of the garment body to identify truth of an incontinence event and validate the predicted incontinence risk (Brink: Para. [0049]; [0065-0066] ‘undergarment’, ‘moisture sensor’),
wherein the incontinence event detector is a moisture sensor, a thermistor, or a resistance meter (Brink: Para. [0049]; [0065-0066] ‘undergarment’, ‘moisture sensor’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include an incontinence event detector as taught by Brink to provide information indicative of voiding events that occur (Brink: Para. [0049]; [0065-0066])
Regarding Claim 18, Loughney in view of Brink discloses the garment of claim 17, Loughney further discloses validation with historical data comprising EIT images since an initial usage of the EIT device by the user (Loughney: Pg. 16, line 27-Pg. 17, line 1; Pg. 18, lines 24-27 & Fig. 18A-F; Pg. 7, lines 16-17; Note: Examiner interpretation of Full status is based on the bladder just prior to micturition which is interpreted to be a ‘maximum bladder tolerance of the user’… a full bladder is the same as a largest liquid volume in the bladder, the images can be measured against a baseline that includes measurements taken just before micturition (full bladder) and after micturition (empty bladder) and between (during filling).).
Loughney is silent on an incontinence event detector and an incontinence prediction module.
However, Brink teaches an incontinence event detector to identify truth of an incontinence event (Brink: Para. [0049]; [0065-0066] ‘moisture sensor’),
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney to include an incontinence event detector as taught by Brink to provide information indicative of voiding events that occur (Brink: Para. [0049]; [0065-0066])
Loughney in view of Brink is silent on an incontinence prediction module.
However, Hwang teaches wherein the incontinence prediction module is validated with historical data comprising user postures, images, and truth of user incontinence events generated since an initial usage of the image device by the user (Hwang: Para. [0077]; [0017] and [0095]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the EIT device of Loughney in view of Brink to include an incontinence prediction module that is pre-trained as taught by Hwang to monitor bladder status in real time with less data resources and time-consumed. (Hwang: Para. [0017]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loughney in view of Brink in view of US 20220288389 A1 to Denison et al. (hereinafter, Denison).
Regarding Claim 7, Loughney in view of Brink discloses the system of claim 1, Loughney further discloses wherein the EIT device further comprises an analog-to-digital converter to generate real parts and image parts of electrical impedance (Loughney: Pg. 14, lines 3-10 & lines 23-25; An ADC is taught by Loughney. Referring to the interpretation of real parts and image parts in the 112(b) rejection above: It has been determined that real parts and imaginary parts are inherently generated by an analog-to-digital converter, which has been interpreted to be the intent of the limitation. Therefore, due to Loughney disclosing an ADC, Loughney reads on this limitation of this claim.).
Loughney is silent on a AC/DC converter.
However, Denison teaches an AC/DC converter (Denison: Para. [0064]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of Loughney to specify the inclusion of an AC/DC converter to rectify the signal as a signal processing standard, converting the alternating current to a direct current as is understood by one of ordinary skill in the art (Denison: Para. [0064]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loughney in view of Brink in view of US 20130002264 A1 to Garber.
Regarding Claim 12, Loughney in view of Brink discloses the garment of claim 11, Loughney further discloses wherein the plurality of electrodes of the EIT device comprises a first two or more electrodes are configured and a second two or more electrodes record resulting potentials detected in the body of the user (Loughney: Pg. 11, lines 10-11 ‘The electrodes may be in direct conductive contact or capacitively coupled to the body surface.’; Pg. 14, lines 13-17.),
wherein the electrodes are allocated in a belt shape for 2D EIT imaging or in a multiple-array structure for 3D EIT imaging (Loughney: Pg. 17, lines 17-21; Figs. 5A & 5B; Pg. 17, lines 22-24; Pg. 19, lines 1-5).
Loughney is silent on the current applied to a body of the user being an alternating current.
However, Garber teaches applying alternating current to a body of a user for electrical impedance tomography (Garber: Para. [0002]; [0004]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify Loughney to specify the current being alternating current as taught by Garber. This combination of prior art elements according to known methods would yield predictable results, in this case, to allow probing of frequency-dependent tissue properties.
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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